News
Organon unveils study of medical device for postpartum haemorrhage control
Postpartum haemorrhage is a severe vaginal bleeding that can occur within a day of giving birth or up to 12 weeks postpartum
The women’s health company Organon has announced the first observational study of its medical device for postpartum haemorrhage control.
The company has said that the Obstetrics & Gynecology journal published the results of the RUBY study which reached its primary effectiveness outcome of treating abnormal postpartum uterine bleeding and postpartum haemorrhage (PPH) with Organon’s JADA System.
JADA is an intrauterine vacuum-induced haemorrhage control device intended to provide control and treatment of abnormal PPH, a severe vaginal bleeding after childbirth that can occur within a day of giving birth or up to 12 weeks postpartum.
“PPH is a potentially life-threatening obstetric emergency that can occur after childbirth and requires timely medical intervention,” explained lead author Dena Goffman, a maternal-foetal medicine subspecialist, and professor and vice chair for quality and patient safety in the Department of Obstetrics and Gynecology at Columbia University Irving Medical Center in New York.
“Appropriate management of abnormal postpartum uterine bleeding is critical to minimise the potential clinical consequences of PPH and its associated severe maternal morbidities, such as the need for blood transfusions, ICU admission or hysterectomy.
“The new study, which included a larger population than the pivotal trial, showed how the device is being used outside of a controlled clinical trial environment.
“The results indicate that the intrauterine vacuum-induced haemorrhage control device is an important tool for PPH management.”
The study assessed records of 800 patients across 16 US hospitals from October 2020 through March 2022 and evaluated JADA treatment of abnormal postpartum uterine bleeding and PPH in “real-world” settings.
Treatment success was defined as bleeding control after insertion with no treatment escalation or bleeding recurrence.
According to Organon, JADA achieved treatment success in both the vaginal (92.5 per cent) and cesarean birth (83.7 per cent) groups, regardless of the cause of the abnormal PPH.
When reviewing patient cases that received standard PPH interventions plus the JADA System, lower blood loss prior to device insertion was associated with lower severe maternal morbidity.
Patricia Carney, Organon director of medical affairs, said: “Severe maternal morbidity rates in the US are rising, and PPH is recognised as a major cause of some of these morbidities.
“While severe maternal morbidities occurred even at lower levels of blood loss in this study, higher rates of morbidity were associated with higher levels of blood loss prior to JADA treatment in conjunction with other interventions that may have been used.
“These data shed light on the importance of appropriate control of blood loss, and it’s encouraging that the RUBY study reinforced the JADA pivotal study results in a real-world setting.”
Organon said adverse events in RUBY were consistent with the study PEARLE and what would be expected when managing an obstetric emergency.
Three serious adverse device events were deemed possibly related to the device or procedure, all of which resolved with treatment, the company added.
Diagnosis
Lung cancer drug shows breast cancer potential
Ovarian cancer cells quickly activate survival responses after PARP inhibitor treatment, and a lung cancer drug could help block this, research suggests.
PARP inhibitors are a common treatment for ovarian cancer, particularly in tumours with faulty DNA repair. They stop cancer cells fixing DNA damage, which leads to cell death, but many tumours later stop responding.
Researchers identified a way cancer cells may survive PARP inhibitor treatment from the outset, pointing to a potential way to block that response. A Mayo Clinic team found ovarian cancer cells rapidly switch on a pro-survival programme after exposure to PARP inhibitors. A key driver is FRA1, a transcription factor (a protein that turns genes on and off) that helps cancer cells adapt and avoid death.
The team then tested whether brigatinib, a drug approved for certain lung cancers, could block this response and boost the effect of PARP inhibitors. Brigatinib was chosen because it inhibits multiple signalling pathways involved in cancer cell survival.
In laboratory studies, combining brigatinib with a PARP inhibitor was more effective than either treatment alone. Notably, the effect was seen in cancer cells but not normal cells, suggesting a more targeted approach.
Brigatinib also appeared to act in an unexpected way. Rather than working through the usual DNA repair routes, it shut down two signalling molecules, FAK and EPHA2, that aggressive ovarian cancer cells rely on. FAK and EPHA2 are proteins that relay survival signals inside cells. Blocking both at once weakened the cells’ ability to adapt and resist treatment, making them more vulnerable to PARP inhibitors.
Tumours with higher levels of FAK and EPHA2 responded better to the drug combination. Other data link high levels of these molecules to more aggressive disease, pointing to potential benefit in harder-to-treat cases.
Arun Kanakkanthara, an oncology investigator at Mayo Clinic and a senior author of the study, said: “This work shows that drug resistance does not always emerge slowly over time; cancer cells can activate survival programmes very early after treatment begins.”
John Weroha, a medical oncologist at Mayo Clinic and a senior author of the study, said: “From a clinical perspective, resistance remains one of the biggest challenges in treating ovarian cancer. By combining mechanistic insights from Dr Kanakkanthara’s laboratory with my clinical experience, this preclinical work supports the strategy of targeting resistance early, before it has a chance to take hold. This strategy could improve patient outcomes.”
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